Atopic DermatitisPhase 2NCT02914548
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis
A Phase 2 study testing OPA-15406 in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Co., Ltd. at 3 sites in Japan.
Trial summary
The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- OPA-15406
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesJapan
- Study dates
- Sep 2016to Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
Who cannot join
- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- Subjects who have an active viral skin infection.
- Subjects with a current or history of malignancy.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kiniki Region
About this study
Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Assess the Efficacy and Safety of 0.3% and 1% OPA-15406 Ointments in Patients With Atopic Dermatitis
The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- OPA-15406, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPA-15406Drug
Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
PlaceboDrug
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 0.3% OPA-15406 | Experimental | Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. Receives: Drug: OPA-15406 |
| 1% OPA-15406 | Experimental | Subjects were treated with assigned 1% OPA-15406 ointment twice daily. Receives: Drug: OPA-15406 |
| Placebo | Placebo comparator | Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
The investigator or sub investigator assessed the skin symptoms using IGA. The investigator or sub investigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week4. Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
Measured: At Week 4
Secondary outcomes (9)
Change From Baseline in Eczema Area and Severity Index (EASI) Score
The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.
Measured: Baseline, Week 4
Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
The investigator or subinvestigator evaluated the level of pruritus based on VAS. The subjects will mark the point of pruritus intensity during the last 24 hours on the line of a 100- mm VAS sheet between the left end (no pruritus: the score is 0 ) and the right end (very severe pruritus: the score is 100), and a negative change from the baseline means improvement and a positive change means worsening. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded
Measured: Baseline, Week 4
Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary.
0 : None
- : Mild
- : Moderate
- : Severe For subjects aged 2 to 6 years, this would not be evaluated. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.
Measured: Baseline, Hour 156
Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
The investigator or sub investigator evaluated eczema according to the POEM. The subjects answered 7 questions about their eczema by 0-4 points per question. The POEMS's minimum and maximum scores are 0 and 28 scores respectively. The higher the POEM score is, the more severe the symptoms are, and a negative change from the baseline means improvement and a positive change means worsening. If it is difficult for subjects to answer the questions, their parents answered them instead. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.
Measured: Baseline, Week 4
Change From Baseline in Percentage Affected Body Surface Area
The investigator or subinvestigator drew the affected BSA (range of skin eruption at the time of examination) on the human body drawing to determine the affected areas (%) on the respective 4 body regions (face, neck, and head; upper limbs; trunk; and lower limbs). One palm of the subject corresponds to 1% BSA.
Measured: Baseline, Week 4
Mean (SD) OPA-15406 Plasma Trough Concentrations
The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.
Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded.
Measured: Week1, Week4, Week8
Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA
The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded.
Measured: Week1, Week4, Week8
OPA-15406 Plasma PK Parameters, Cmax
OPA-15406 plasma PK parameter (Cmax) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point. Participants who have no effective data were excluded.
Measured: Day 1 and Week 4
OPA-15406 Plasma PK Parameters, AUC8h
OPA-15406 plasma PK parameter (AUC8h) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point. Participants who have no effective data were excluded.
Measured: Day 1 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroaki Ono, Mr, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914548
- Sponsor's protocol ID
- 271-15-001
- Other IDs
- JapicCTI-163372
- Status last verified
- Jun 2020
- First submitted
- 8 Sep 2016
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Assess the Efficacy and Safety of 0.3% and 1% OPA-15406 Ointments in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02914548
- Acronym / sponsor ID
- 271-15-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 29 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.3% OPA-15406 | Experimental | Drug: OPA-15406Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. |
| 1% OPA-15406 | Experimental | Drug: OPA-15406Subjects were treated with assigned 1% OPA-15406 ointment twice daily. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects were treated with assigned 0% OPA-15406 ointment twice daily. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
Key exclusion criteria (3 listed)
- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- Subjects who have an active viral skin infection.
- Subjects with a current or history of malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPA-15406Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily. | Drug | 0.3% OPA-15406, 1% OPA-15406 |
| PlaceboSubjects were treated with assigned 0% OPA-15406 ointment twice daily. | Drug | Placebo |
Primary outcome
Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
Time frame: At Week 4
The investigator or sub investigator assessed the skin symptoms using IGA. The investigator or sub investigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week4. Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
9 secondary outcomes
Change From Baseline in Eczema Area and Severity Index (EASI) Score
Time frame: Baseline, Week 4
Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
Time frame: Baseline, Week 4
Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
Time frame: Baseline, Hour 156
Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
Time frame: Baseline, Week 4
Change From Baseline in Percentage Affected Body Surface Area
Time frame: Baseline, Week 4
Mean (SD) OPA-15406 Plasma Trough Concentrations
Time frame: Week1, Week4, Week8
Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA
Time frame: Week1, Week4, Week8
OPA-15406 Plasma PK Parameters, Cmax
Time frame: Day 1 and Week 4
OPA-15406 Plasma PK Parameters, AUC8h
Time frame: Day 1 and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroaki Ono, Mr study director
Otsuka Pharmaceutical Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPA-15406 in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Co., Ltd. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4 (time frame: At Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.